Brand Name | BD VACUTAINER® ACD-B 1.5 ML BLOOD COLLECTION TUBE |
Type of Device | BLOOD SPECIMEN COLLECTION DEVICE |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY (BD) |
belliver way |
belliver industrial estate |
plymouth |
UK |
|
Manufacturer (Section G) |
BECTON, DICKINSON AND COMPANY (BD) |
belliver way |
belliver industrial estate |
plymouth |
UK
|
|
Manufacturer Contact |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8448235433
|
|
MDR Report Key | 16695310 |
MDR Text Key | 312859696 |
Report Number | 9617032-2023-00361 |
Device Sequence Number | 1 |
Product Code |
JKA
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/23/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 09/30/2023 |
Device Catalogue Number | 367756 |
Device Lot Number | 2090609 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/17/2023
|
Initial Date FDA Received | 04/06/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/31/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|